On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013. The final guidance is largely similar to the draft, with the exception of the pre-decisional IDE process. As we noted in our blog post on the draft guidance, it was not clear how the pre-decisional IDE process would actually benefit sponsors, since the timeframe for review was essentially the same as without the process.

In the Federal Register notice announcing the draft guidance, FDA specifically sought feedback on the utility of the pre-decisional process. In its notice announcing the final guidance, FDA stated: “Some commenters expressed support for the proposal and felt that it might shorten the time to full approval of pivotal IDE studies. Other commenters expressed concern that the Pre-Decisional IDE process itself might be too time-consuming or require extensive FDA resources that could be better allocated elsewhere. Based on the comments received and FDA’s consideration of the points raised, FDA will not pursue the Pre-Decisional IDE at the present time.” 79 Fed. Reg. 49089, 49090 (Aug. 19, 2014).

There are two other changes that relate to how information will be conveyed by FDA to the IDE sponsor. In both the draft and final guidance, FDA states that, if it “identifies concerns unrelated to subject safety which the Agency believes should be addressed to enable the study to support the sponsor’s stated goals (e.g., a future marketing application or future study), FDA intends to communicate these ‘study design considerations’ [SDCs] to the sponsor.”

In the draft guidance, FDA proposed that these SDCs be included in a section of the IDE decision letter. In the Federal Register notice announcing the final guidance—but not in the final guidance itself—FDA states that it will provide the SDCs in a separate attachment included with the IDE decision letter. It is doing so because it “believes that sponsors and other stakeholders may misinterpret SDCs included in the body of a decision letter as issues that are required to be addressed.” The SDC letter will state: “These recommendations do not relate to the safety, rights or welfare of study subjects, and they do not need to be addressed in order for you to conduct your study.’’ Id.

FDA also intends to convey “future considerations” in a separate letter. “Future considerations” are “issues or recommendations that FDA believes the sponsor should consider in preparing for a marketing application or a future clinical investigation but which FDA does not deem necessary to address to enable the current study to support its stated goals.”

One thing that unfortunately did not change from the draft guidance is the language FDA uses with respect to the study design assessment. The final guidance states that FDA’s decision letter will specify whether FDA believes that “the study design is adequate and may support a future marketing approval or clearance, if it is successfully executed and meets its stated endpoints without raising unforeseen safety concerns.” Guidance, at 12 (emphasis added). It is not clear why FDA cannot say that if the study design is adequate, it will support a future marketing approval or clearance, if it meets its endpoints and does not raise unforeseen safety concerns. The statement about the endpoints and safety concerns is not even the entire caveat FDA provides; the guidance also states that “FDA intends to consider changes to its assessment of the study design only if the sponsor materially changes the device or the study design or important issues relevant to a determination of safety or effectiveness have emerged since it approved the IDE.” FDA therefore seems to have given itself sufficient “outs” and should be willing to state “will” rather than “may.” Also, it is interesting to note that FDA only “intends” to change its assessment if certain circumstances arise; it will not commit to only changing its position in those circumstances. Given all of the qualifying language with respect to a statement that a study design is adequate, FDA is not guaranteeing that a successful study will yield a clearance or approval. On the other hand, FDA should need to shoulder a high burden to justify changing its views.